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Clinical trial from center trial watch

From Sherri, March 30, 2005

Trial Information Summary: Immunotherapy versus Placebo for Patients with Stage IV Melanoma. This is a Phase 3 study in patients with stage IV melanoma (which means that the melanoma has spread to distant sites) and who have had all melanoma surgically removed. The purpose of this study is to show whether or not Canvaxin ™ immunotherapy can prevent or slow the recurrence of melanoma. Participants will receive either Canvaxin ™ immunotherapy or placebo. Both groups will also receive BCG (Bacillus Calmette-Guerin), which is commonly used to stimulate the immune system. Injections are given every two weeks for the first two months, then monthly for the rest of year 1, every two months for year 2, and every three months for years 3-5. To be included in this study, the following basic criteria must be met: Must have Stage IV melanoma Must have had all clinically-detectable disease surgically removed or treated with stereotactic radiation Cannot be taking any medications, or undergoing any therapies which compromise the functioning of your immune system (for example, some corticosteroids) Cannot have HIV Contact: Lydia Giles Fox Chase Cancer Center Protocol Management Office 333 Cottman Avenue Philadelphia, PA 19111 Telephone: 215-728-5663 Fax: 215-728-2687 Email: l_giles@fccc.edu Provided by